DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic qual...
FDA Device Recall #Z-2175-2014 — Class II — July 2, 2014
Recall Summary
| Recall Number | Z-2175-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 2, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | AGFA Healthcare Corp. |
| Location | Greenville, SC |
| Product Type | Devices |
| Quantity | 17 units |
Product Description
DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.
Reason for Recall
Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.
Distribution Pattern
Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada
Lot / Code Information
Serial Nos. A5430000089, A5430000131, A5430000015, A5430000095, A5430000052, A5430000061, A5430000079, A5430000030, A5430000042, A5430000066, A5430000081, A5430000085, A5430000096, A5430000020, A5430000067, A5430000125, A5430000105
Other Recalls from AGFA Healthcare Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0923-2026 | Class II | Brand name: AGFA Digital Radiography X- Ray sys... | Nov 18, 2025 |
| Z-2652-2017 | Class II | IMPAX Cardiovascular The IMPAX CV Reporting mo... | Dec 22, 2016 |
| Z-2735-2017 | Class II | Agfa Healthcare NX 3.0.8950 Imaging Processing ... | Dec 21, 2016 |
| Z-1738-2017 | Class II | DX-D600 - DXD Imaging Package | May 2, 2016 |
| Z-1698-2017 | Class II | AGFA Digital Radiography X-Ray System DX-D100 ... | Jan 20, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.